Argon Medical Productions & Vertrieb Gesellschaft MBH & CO FDA Record
- Latest inspection OAI · Jul 31, 2024
- Last warning letter 2024
Argon Medical Productions & Vertrieb Gesellschaft MBH & CO has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 2 warning letters to Argon Medical Productions & Vertrieb Gesellschaft MBH & CO, the most recent on Nov 22, 2024.
- Latest inspection
- Jul 31, 2024 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Argon Medical Productions & Vertrieb Gesellschaft MBH & CO FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 22, 2024 · Letter on fda.gov | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Center for Devices and Radiological Health | |
| Oct 22, 2024 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 31, 2024 | Bingen Am Rhein, Germany | Devices | Official Action Indicated (OAI) | 3011575197 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Argon Medical Productions & Vertrieb Gesellschaft MBH & CO: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011575197 | Bingen Am Rhein, Germany | 1 | Jul 31, 2024 |
Argon Medical Productions & Vertrieb Gesellschaft MBH & CO and the FDA: common questions
Has Argon Medical Productions & Vertrieb Gesellschaft MBH & CO received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Argon Medical Productions & Vertrieb Gesellschaft MBH & CO. The most recent is dated Nov 22, 2024, with the subject "CGMP/QSR/Medical Devices/Adulterated/Misbranded".
Has Argon Medical Productions & Vertrieb Gesellschaft MBH & CO received an FDA Form 483?
FDA has not published a Form 483 for "Argon Medical Productions & Vertrieb Gesellschaft MBH & CO" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Argon Medical Productions & Vertrieb Gesellschaft MBH & CO?
The most recent FDA inspection on file ended Jul 31, 2024 at Bingen Am Rhein, Germany and was classified OAI. FDA has 1 inspection of Argon Medical Productions & Vertrieb Gesellschaft MBH & CO on file, 1 of them classified OAI (official action indicated).
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